REGULATORY GUIDANCE SERVICES
RGS – The Regulatory Guidance Services group is comprised of elite team members and conducts high-level regulatory and litigation consulting services to companies world wide. Support includes consulting for production and manufacturing facility design, regulatory strategic planning and due diligence for US and International based customers or projects that need extensive and relevant industry expertise.
RGS is brought in to advise on facility planning or investment initiatives, assess compliance risks, as well as provide hands-on management of such programs to better ensure successful operational launches, investigations, or mitigate high-risk legal and regulatory matters throughout the Food, Dietary Supplement, Cosmetic and Homeopathic industries.
The types of programs managed include:
• Facility Design & Production Consulting for Processing or Manufacturing and Distribution operations
• GRAS Self-affirmations, GRAS w/ FDA Notifications
• Electronic New Dietary Ingredient Notifications (eNDIN’s)
• Litigation Consulting & Expert Witness Testimony services
……….• Sales & Marketing, Forecasting, Compensation Planning
……….• Quality Control, Quality Assurance
……….• Regulatory Agency Actions (FDA, FTC, etc.)
……….• Claim Substantiations
……….• Contamination, Adulteration and Counterfeit products
• Quality System Optimization
……….• Quality & Regulatory Strategy Planning
……….• Budgeting, Risk Evaluations, KPI’s
• International Regulatory Management & Due Diligence